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The I-SPY Program is committed to open science, through timely publication and release of results, and ultimately data, from all arms of our trials.
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Featured Publications

New Engl J Med
July 7, 2016
valiparib + carboplatin graduates from I-SPY2

Published Manuscripts

Wolf DM, Yau C, Wulfkuhle J, et al.
Mechanism of action biomarkers predicting response to AKT inhibition in the I-SPY 2 breast cancer trial
.
npj Breast Cancer
6
:
48
, 
2020
.
abstract
pdf
original
Wolf DM, Yau C, Wulfkuhle J, et al.
Mechanism of action biomarkers predicting response to AKT inhibition in the I-SPY 2 breast cancer trial
. In 
 (Eds.), 
npj Breast Cancer
6
(
); pp.
48
, 
2020
.
abstract
pdf
link
I-SPY Trial Consortium
Association of Event-Free and Distant Recurrence–Free Survival With Individual-Level Pathologic Complete Response in Neoadjuvant Treatment of Stages 2 and 3 Breast Cancer
.
JAMA Oncol
6
:
1355-1362
, 
2020
.
abstract
pdf
original
I-SPY Trial Consortium
Association of Event-Free and Distant Recurrence–Free Survival With Individual-Level Pathologic Complete Response in Neoadjuvant Treatment of Stages 2 and 3 Breast Cancer
. In 
 (Eds.), 
JAMA Oncol
6
(
); pp.
1355-1362
, 
2020
.
abstract
pdf
link
Arasu VA, Kim P, Li W, et al.
Predictive Value of Breast MRI Background Parenchymal Enhancement for Neoadjuvant Treatment Response among HER2− Patients
.
J Breast Imaging
2
:
352-360
, 
2020
.
abstract
pdf
original
Arasu VA, Kim P, Li W, et al.
Predictive Value of Breast MRI Background Parenchymal Enhancement for Neoadjuvant Treatment Response among HER2− Patients
. In 
 (Eds.), 
J Breast Imaging
2
(
); pp.
352-360
, 
2020
.
abstract
pdf
link
Li W, Newitt DC, Yun BL, et al.
Tumor Sphericity Predicts Response in Neoadjuvant Chemotherapy for Invasive Breast Cancer
.
Tomogr
6
:
216-222
, 
2020
.
abstract
pdf
original
Li W, Newitt DC, Yun BL, et al.
Tumor Sphericity Predicts Response in Neoadjuvant Chemotherapy for Invasive Breast Cancer
. In 
 (Eds.), 
Tomogr
6
(
); pp.
216-222
, 
2020
.
abstract
pdf
link
Nanda R, Liu MC, Yau C, et al.
Effect of Pembrolizumab Plus Neoadjuvant Chemotherapy on Pathologic Complete Response in Women With Early-Stage Breast Cancer
.
JAMA Oncol
6
:
676-684
, 
2020
.
abstract
pdf
original
Nanda R, Liu MC, Yau C, et al.
Effect of Pembrolizumab Plus Neoadjuvant Chemotherapy on Pathologic Complete Response in Women With Early-Stage Breast Cancer
. In 
 (Eds.), 
JAMA Oncol
6
(
); pp.
676-684
, 
2020
.
abstract
pdf
link
Chien AJ, Tripathy D, Albain KS, et al.
MK-2206 and Standard Neoadjuvant Chemotherapy Improves Response in Patients With Human Epidermal Growth Factor Receptor 2–Positive and/or Hormone Receptor–Negative Breast Cancers in the I-SPY 2 Trial
.
J Clin Oncol
38
:
1059-1069
, 
2020
.
abstract
pdf
original
Chien AJ, Tripathy D, Albain KS, et al.
MK-2206 and Standard Neoadjuvant Chemotherapy Improves Response in Patients With Human Epidermal Growth Factor Receptor 2–Positive and/or Hormone Receptor–Negative Breast Cancers in the I-SPY 2 Trial
. In 
 (Eds.), 
J Clin Oncol
38
(
); pp.
1059-1069
, 
2020
.
abstract
pdf
link
Piawah S, Hyland C, Umetsu SE, et al.
A case report of vanishing bile duct syndrome after exposure to pexidartinib (PLX3397) and paclitaxel
.
npj Breast Cancer
5
:
17
, 
2019
.
abstract
pdf
original
Piawah S, Hyland C, Umetsu SE, et al.
A case report of vanishing bile duct syndrome after exposure to pexidartinib (PLX3397) and paclitaxel
. In 
 (Eds.), 
npj Breast Cancer
5
(
); pp.
17
, 
2019
.
abstract
pdf
link
Li W, Newitt DC, Wilmes LJ, et al.
Additive value of diffusion-weighted MRI in the I-SPY 2 TRIAL
.
J Magn Reson Imaging
50
:
1742-1753
, 
2019
.
abstract
pdf
original
Li W, Newitt DC, Wilmes LJ, et al.
Additive value of diffusion-weighted MRI in the I-SPY 2 TRIAL
. In 
 (Eds.), 
J Magn Reson Imaging
50
(
); pp.
1742-1753
, 
2019
.
abstract
pdf
link
Esserman L, Hylton N, Asare S, et al.
I-SPY2: Unlocking the Potential of the Platform Trial
.
:
3-22
, 
2018
.
abstract
pdf
original
Esserman L, Hylton N, Asare S, et al.
I-SPY2: Unlocking the Potential of the Platform Trial
. In 
Z. Antonijevic & R. A. Beckman
 (Eds.), 
Platform Trial Designs in Drug Development: Umbrella Trials and Basket Trials
(
Chapman and Hall/CRC
); pp.
3-22
, 
2018
.
abstract
pdf
link
Newitt DC, Zheng Z, Gibbs JE, et al.
Test–retest repeatability and reproducibility of ADC measures by breast DWI: Results from the ACRIN 6698 trial
.
J Mag Res Imag
49
:
1617-1628
, 
2019
.
abstract
pdf
original
Newitt DC, Zheng Z, Gibbs JE, et al.
Test–retest repeatability and reproducibility of ADC measures by breast DWI: Results from the ACRIN 6698 trial
. In 
 (Eds.), 
J Mag Res Imag
49
(
); pp.
1617-1628
, 
2019
.
abstract
pdf
link
Partridge SC, Zhang Z, Newitt DC, et al
Diffusion-weighted MRI Findings Predict Pathologic Response in Neoadjuvant Treatment of Breast Cancer: The ACRIN 6698 Multicenter Trial
.
Radiol
289
:
618-627
, 
2018
.
abstract
pdf
original
Partridge SC, Zhang Z, Newitt DC, et al
Diffusion-weighted MRI Findings Predict Pathologic Response in Neoadjuvant Treatment of Breast Cancer: The ACRIN 6698 Multicenter Trial
. In 
 (Eds.), 
Radiol
289
(
); pp.
618-627
, 
2018
.
abstract
pdf
link
Boughey JC, Alvarado MD, Lancaster RB, et al.
Surgical Standards for Management of the Axilla in Breast Cancer Clinical Trials with Pathological Complete Response Endpoint
.
npj Breast Cancer
4
:
26
, 
2018
.
abstract
pdf
original
Boughey JC, Alvarado MD, Lancaster RB, et al.
Surgical Standards for Management of the Axilla in Breast Cancer Clinical Trials with Pathological Complete Response Endpoint
. In 
 (Eds.), 
npj Breast Cancer
4
(
); pp.
26
, 
2018
.
abstract
pdf
link
Wulfkuhle JD, Yau C, Wolf DM, et al
Evaluation of the HER/PI3K/AKT Family Signaling Network as a Predictive Biomarker of Pathologic Complete Response for Patients With Breast Cancer Treated With Neratinib in the I-SPY 2 TRIAL
.
JCO Precision Oncology
2
:
1-20
, 
2018
.
abstract
pdf
original
Wulfkuhle JD, Yau C, Wolf DM, et al
Evaluation of the HER/PI3K/AKT Family Signaling Network as a Predictive Biomarker of Pathologic Complete Response for Patients With Breast Cancer Treated With Neratinib in the I-SPY 2 TRIAL
. In 
 (Eds.), 
JCO Precision Oncology
2
(
); pp.
1-20
, 
2018
.
abstract
pdf
link
Scheel JR, Kim E, Partridge SC, et al.
MRI, Clinical Examination, and Mammography for Preoperative Assessment of Residual Disease and Pathologic Complete Response After Neoadjuvant Chemotherapy for Breast Cancer: ACRIN 6657 Trial
.
Am J Roentgenol
210
:
1376-1385
, 
2018
.
abstract
pdf
original
Scheel JR, Kim E, Partridge SC, et al.
MRI, Clinical Examination, and Mammography for Preoperative Assessment of Residual Disease and Pathologic Complete Response After Neoadjuvant Chemotherapy for Breast Cancer: ACRIN 6657 Trial
. In 
 (Eds.), 
Am J Roentgenol
210
(
); pp.
1376-1385
, 
2018
.
abstract
pdf
link
Olshen A, Wolf D, Jones EF, et al.
Features of MRI stromal enhancement with neoadjuvant chemotherapy: a subgroup analysis of the ACRIN 6657/I-SPY TRIAL
.
J Med Imaging
5
:
11014
, 
2018
.
abstract
pdf
original
Olshen A, Wolf D, Jones EF, et al.
Features of MRI stromal enhancement with neoadjuvant chemotherapy: a subgroup analysis of the ACRIN 6657/I-SPY TRIAL
. In 
 (Eds.), 
J Med Imaging
5
(
); pp.
11014
, 
2018
.
abstract
pdf
link
Wolf DM, Yau C, Sanil A, et al.
DNA repair deficiency biomarkers and the 70-gene ultra-high risk signature as predictors of veliparib/carboplatin response in the I-SPY 2 breast cancer trial
.
npj Breast Cancer
3
:
, 
2017
.
abstract
pdf
original
Wolf DM, Yau C, Sanil A, et al.
DNA repair deficiency biomarkers and the 70-gene ultra-high risk signature as predictors of veliparib/carboplatin response in the I-SPY 2 breast cancer trial
. In 
 (Eds.), 
npj Breast Cancer
3
(
); pp.
, 
2017
.
abstract
pdf
link
Severson TM, Wolf DM, Yau C, et al.
The BRCA1 ness signature is associated significantly with response to PARP inhibitor treatment versus control in the I-SPY 2 randomized neoadjuvant setting
.
Breast Cancer Res
19
:
99
, 
2017
.
abstract
pdf
original
Severson TM, Wolf DM, Yau C, et al.
The BRCA1 ness signature is associated significantly with response to PARP inhibitor treatment versus control in the I-SPY 2 randomized neoadjuvant setting
. In 
 (Eds.), 
Breast Cancer Res
19
(
); pp.
99
, 
2017
.
abstract
pdf
link
Campbell JI, Yau C, Krass P, et al.
Comparison of residual cancer burden, American Joint Committee on Cancer staging and pathologic complete response in breast cancer after neoadjuvant chemotherapy: results from the I-SPY 1 TRIAL (CALGB 150007/150012; ACRIN 6657).
.
Breast Cancer Res Treat
165
:
181-191
, 
2017
.
abstract
pdf
original
Campbell JI, Yau C, Krass P, et al.
Comparison of residual cancer burden, American Joint Committee on Cancer staging and pathologic complete response in breast cancer after neoadjuvant chemotherapy: results from the I-SPY 1 TRIAL (CALGB 150007/150012; ACRIN 6657).
. In 
 (Eds.), 
Breast Cancer Res Treat
165
(
); pp.
181-191
, 
2017
.
abstract
pdf
link
Li W, Arasu V, Newitt DC, et al.
Effect of MR Imaging Contrast Thresholds on Prediction of Neoadjuvant Chemotherapy Response in Breast Cancer Subtypes: A Subgroup Analysis of the ACRIN 6657/I-SPY 1 TRIAL.
.
Tomography
2
:
378-387
, 
2016
.
abstract
pdf
original
Li W, Arasu V, Newitt DC, et al.
Effect of MR Imaging Contrast Thresholds on Prediction of Neoadjuvant Chemotherapy Response in Breast Cancer Subtypes: A Subgroup Analysis of the ACRIN 6657/I-SPY 1 TRIAL.
. In 
 (Eds.), 
Tomography
2
(
); pp.
378-387
, 
2016
.
abstract
pdf
link
Rugo HS, Olopade, OI, DeMichele A, et al.
Adaptive randomization of veliparib-carboplatin treatment in breast cancer
.
New Engl J Med
375
:
23-34
, 
2016
.
abstract
pdf
original
Rugo HS, Olopade, OI, DeMichele A, et al.
Adaptive randomization of veliparib-carboplatin treatment in breast cancer
. In 
 (Eds.), 
New Engl J Med
375
(
); pp.
23-34
, 
2016
.
abstract
pdf
link
Park JW, Liu MC, Yee D, et al.
Adaptive Randomization of Neratinib in Early Breast Cancer
.
N Engl J Med
375
:
11-22
, 
2016
.
abstract
pdf
original
Park JW, Liu MC, Yee D, et al.
Adaptive Randomization of Neratinib in Early Breast Cancer
. In 
 (Eds.), 
N Engl J Med
375
(
); pp.
11-22
, 
2016
.
abstract
pdf
link
Magbanua MJM, Wolf DM, Yau C, et al.
Serial expression analysis of breast tumors during neoadjuvant chemotherapy reveals changes in cell cycle and immune pathways associated with recurrence and response
.
Breast Cancer Res
17
:
73
, 
2015
.
abstract
pdf
original
Magbanua MJM, Wolf DM, Yau C, et al.
Serial expression analysis of breast tumors during neoadjuvant chemotherapy reveals changes in cell cycle and immune pathways associated with recurrence and response
. In 
 (Eds.), 
Breast Cancer Res
17
(
); pp.
73
, 
2015
.
abstract
pdf
link
DeMichele A, Yee D, Berry D, et al.
The Neoadjuvant Model Is Still the Future for Drug Development in Breast Cancer
.
Clinical Cancer Research
21
:
2911-2915
, 
2015
.
abstract
pdf
original
DeMichele A, Yee D, Berry D, et al.
The Neoadjuvant Model Is Still the Future for Drug Development in Breast Cancer
. In 
 (Eds.), 
Clinical Cancer Research
21
(
); pp.
2911-2915
, 
2015
.
abstract
pdf
link
Price ER, Wong J, Mukhtar R, et al
How to use magnetic resonance imaging following neoadjuvant chemotherapy in locally advanced breast cancer
.
World J Clinical Cases
3
:
607-613
, 
2015
.
abstract
pdf
original
Price ER, Wong J, Mukhtar R, et al
How to use magnetic resonance imaging following neoadjuvant chemotherapy in locally advanced breast cancer
. In 
 (Eds.), 
World J Clinical Cases
3
(
); pp.
607-613
, 
2015
.
abstract
pdf
link
Clark AS, Chen J, Kapoor S, et al.
Pretreatment vitamin D level and response to neoadjuvant chemotherapy in women with breast cancer on the I‐SPY trial (CALGB 150007/150015/ACRIN6657)
.
Cancer Medicine
3
:
693-701
, 
2014
.
abstract
pdf
original
Clark AS, Chen J, Kapoor S, et al.
Pretreatment vitamin D level and response to neoadjuvant chemotherapy in women with breast cancer on the I‐SPY trial (CALGB 150007/150015/ACRIN6657)
. In 
 (Eds.), 
Cancer Medicine
3
(
); pp.
693-701
, 
2014
.
abstract
pdf
link
Cureton EL, Yau C, Alvarado MD, et al.
Local Recurrence Rates are Low in High-Risk Neoadjuvant Breast Cancer in the I-SPY 1 Trial (CALGB 150007/150012; ACRIN 6657)
.
Ann Surg Oncol
21
:
2889-2896
, 
2014
.
abstract
pdf
original
Cureton EL, Yau C, Alvarado MD, et al.
Local Recurrence Rates are Low in High-Risk Neoadjuvant Breast Cancer in the I-SPY 1 Trial (CALGB 150007/150012; ACRIN 6657)
. In 
 (Eds.), 
Ann Surg Oncol
21
(
); pp.
2889-2896
, 
2014
.
abstract
pdf
link
Alvarez JV, Pan T-C, Ruth J, et al.
Par-4 Downregulation Promotes Breast Cancer Recurrence by Preventing Multinucleation following Targeted Therapy
.
Cancer Cell
24
:
30-44
, 
2013
.
abstract
pdf
original
Alvarez JV, Pan T-C, Ruth J, et al.
Par-4 Downregulation Promotes Breast Cancer Recurrence by Preventing Multinucleation following Targeted Therapy
. In 
 (Eds.), 
Cancer Cell
24
(
); pp.
30-44
, 
2013
.
abstract
pdf
link
Mukhtar RA, Yau C, Rosen M, et al.
Clinically Meaningful Tumor Reduction Rates Vary by Prechemotherapy MRI Phenotype and Tumor Subtype in the I-SPY 1 TRIAL (CALGB 150007/150012; ACRIN 6657)
.
Ann Surg Oncol
20
:
3823-3830
, 
2013
.
abstract
pdf
original
Mukhtar RA, Yau C, Rosen M, et al.
Clinically Meaningful Tumor Reduction Rates Vary by Prechemotherapy MRI Phenotype and Tumor Subtype in the I-SPY 1 TRIAL (CALGB 150007/150012; ACRIN 6657)
. In 
 (Eds.), 
Ann Surg Oncol
20
(
); pp.
3823-3830
, 
2013
.
abstract
pdf
link
Glück S, de Snoo F, Peeters J, et al.
Molecular subtyping of early-stage breast cancer identifies a group of patients who do not benefit from neoadjuvant chemotherapy.
.
Breast Cancer Res Treat
139
:
759-767
, 
2013
.
abstract
pdf
original
Glück S, de Snoo F, Peeters J, et al.
Molecular subtyping of early-stage breast cancer identifies a group of patients who do not benefit from neoadjuvant chemotherapy.
. In 
 (Eds.), 
Breast Cancer Res Treat
139
(
); pp.
759-767
, 
2013
.
abstract
pdf
link
DeMichele A, Berry DA, Zujewski J, et al.
Developing Safety Criteria for Introducing New Agents into Neoadjuvant Trials
.
Clinical Cancer Research
19
:
2817-2823
, 
2013
.
abstract
pdf
original
DeMichele A, Berry DA, Zujewski J, et al.
Developing Safety Criteria for Introducing New Agents into Neoadjuvant Trials
. In 
 (Eds.), 
Clinical Cancer Research
19
(
); pp.
2817-2823
, 
2013
.
abstract
pdf
link
Yee D, Haddad T, Albain K, et al.
Adaptive trials in the neoadjuvant setting: a model to safely tailor care while accelerating drug development [Correspondence]
.
J. Clin. Oncol.
30
:
Jun-84
, 
2012
.
abstract
pdf
original
Yee D, Haddad T, Albain K, et al.
Adaptive trials in the neoadjuvant setting: a model to safely tailor care while accelerating drug development [Correspondence]
. In 
 (Eds.), 
J. Clin. Oncol.
30
(
); pp.
Jun-84
, 
2012
.
abstract
pdf
link
Esserman LJ, Barker AD, Woodcock J, et al.
A Model for Accelerating Identification and Regulatory Approval of Effective Investigational Agents
.
Cureus
4
:
e76
, 
2012
.
abstract
pdf
original
Esserman LJ, Barker AD, Woodcock J, et al.
A Model for Accelerating Identification and Regulatory Approval of Effective Investigational Agents
. In 
 (Eds.), 
Cureus
4
(
); pp.
e76
, 
2012
.
abstract
pdf
link
Wulfkuhle JD, Berg D, Wolff C, et al.
Molecular Analysis of HER2 Signaling in Human Breast Cancer by Functional Protein Pathway Activation Mapping
.
Clinical Cancer Research
18
:
6426-6435
, 
2012
.
abstract
pdf
original
Wulfkuhle JD, Berg D, Wolff C, et al.
Molecular Analysis of HER2 Signaling in Human Breast Cancer by Functional Protein Pathway Activation Mapping
. In 
 (Eds.), 
Clinical Cancer Research
18
(
); pp.
6426-6435
, 
2012
.
abstract
pdf
link
Esserman LJ, Berry DA, DeMichele A, et al.
Pathologic complete response predicts recurrence-free survival more effectively by cancer subset: results from the I-SPY 1 TRIAL--CALGB 150007/150012, ACRIN 6657
.
J Clin Oncol
30
:
3242-3249
, 
2012
.
abstract
pdf
original
Esserman LJ, Berry DA, DeMichele A, et al.
Pathologic complete response predicts recurrence-free survival more effectively by cancer subset: results from the I-SPY 1 TRIAL--CALGB 150007/150012, ACRIN 6657
. In 
 (Eds.), 
J Clin Oncol
30
(
); pp.
3242-3249
, 
2012
.
abstract
pdf
link
Lips EH, Mukhtar RA, Yau C, et al.
Lobular histology and response to neoadjuvant chemotherapy in invasive breast cancer
.
Breast Cancer Res Treat
136
:
35-43
, 
2012
.
abstract
pdf
original
Lips EH, Mukhtar RA, Yau C, et al.
Lobular histology and response to neoadjuvant chemotherapy in invasive breast cancer
. In 
 (Eds.), 
Breast Cancer Res Treat
136
(
); pp.
35-43
, 
2012
.
abstract
pdf
link
Hylton NM, Blume JD, Bernreuter WK, et al.
Locally Advanced Breast Cancer: MR Imaging for Prediction of Response to Neoadjuvant Chemotherapy—Results from ACRIN 6657/I-SPY TRIAL
.
Radiology
263
:
663-672
, 
2012
.
abstract
pdf
original
Hylton NM, Blume JD, Bernreuter WK, et al.
Locally Advanced Breast Cancer: MR Imaging for Prediction of Response to Neoadjuvant Chemotherapy—Results from ACRIN 6657/I-SPY TRIAL
. In 
 (Eds.), 
Radiology
263
(
); pp.
663-672
, 
2012
.
abstract
pdf
link
Lin C, Buxton MB, Moore D, et al.
Locally advanced breast cancers are more likely to present as Interval Cancers: results from the I-SPY 1 TRIAL (CALGB 150007/150012, ACRIN 6657, InterSPORE Trial)
.
Breast Cancer Res Treat
132
:
871-879
, 
2012
.
abstract
pdf
original
Lin C, Buxton MB, Moore D, et al.
Locally advanced breast cancers are more likely to present as Interval Cancers: results from the I-SPY 1 TRIAL (CALGB 150007/150012, ACRIN 6657, InterSPORE Trial)
. In 
 (Eds.), 
Breast Cancer Res Treat
132
(
); pp.
871-879
, 
2012
.
abstract
pdf
link
Esserman LJ, Berry DA, Cheang MCU, et al.
Chemotherapy response and recurrence-free survival in neoadjuvant breast cancer depends on biomarker profiles: results from the I-SPY 1 TRIAL (CALGB 150007/150012; ACRIN 6657)
.
Breast Cancer Res Treat
132
:
1049-1062
, 
2012
.
abstract
pdf
original
Esserman LJ, Berry DA, Cheang MCU, et al.
Chemotherapy response and recurrence-free survival in neoadjuvant breast cancer depends on biomarker profiles: results from the I-SPY 1 TRIAL (CALGB 150007/150012; ACRIN 6657)
. In 
 (Eds.), 
Breast Cancer Res Treat
132
(
); pp.
1049-1062
, 
2012
.
abstract
pdf
link
Esserman LJ, Woodcock J
Accelerating identification and regulatory approval of investigational cancer drugs
.
JAMA
306
:
2608-2609
, 
2011
.
abstract
pdf
original
Esserman LJ, Woodcock J
Accelerating identification and regulatory approval of investigational cancer drugs
. In 
 (Eds.), 
JAMA
306
(
); pp.
2608-2609
, 
2011
.
abstract
pdf
link
Perlmutter, J
Advocate Involvement in I-SPY 2
.
Breast Disease: A Year Book Quarterly
22
:
21-24
, 
2011
.
abstract
pdf
original
Perlmutter, J
Advocate Involvement in I-SPY 2
. In 
 (Eds.), 
Breast Disease: A Year Book Quarterly
22
(
); pp.
21-24
, 
2011
.
abstract
pdf
link
Barker AD, Sigman CC, Kelloff GJ, et al.
I-SPY 2: an adaptive breast cancer trial design in the setting of neoadjuvant chemotherapy
.
Clinical Pharmacol & Therapeutics
86
:
97-100
, 
2009
.
abstract
pdf
original
Barker AD, Sigman CC, Kelloff GJ, et al.
I-SPY 2: an adaptive breast cancer trial design in the setting of neoadjuvant chemotherapy
. In 
 (Eds.), 
Clinical Pharmacol & Therapeutics
86
(
); pp.
97-100
, 
2009
.
abstract
pdf
link

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